Table 3.
Incidence of common adverse events with lumateperone vs placebo
| Adverse events | No. of studies | Reactions/total | RRs (95% CI)a | I2 (%) | P | |
|---|---|---|---|---|---|---|
| Lumateperone | Placebo | |||||
| Affected subjects by TEAEs | 4 | 289/755 | 190/754 | 1.53 (1.11, 2.12) | 77.44 | .01 |
| TEAEs | 2 | 191/365 | 173/364 | 1.10 (0.95, 1.27) | 0 | .193 |
| Drug-related TEAEs | 2 | 142/365 | 107/364 | 1.32 (1.08, 1.62) | 0 | .007 |
| Somnolence | 6 | 175/1094 | 46/1017 | 3.29 (2.42, 4.47) | 42.53 | <.0001 |
| Dry mouth | 3 | 31/489 | 9/412 | 2.76 (1.35, 5.65) | 39.65 | .006 |
| Dizziness | 6 | 86/1094 | 29/1017 | 2.68 (1.43, 5.38) | 57.11 | .005 |
| Nausea | 6 | 89/1094 | 37/1017 | 2.32 (1.59, 3.38) | 0 | <.0001 |
| Headache | 5 | 156/927 | 121/932 | 1.30 (1.04, 1.62) | 0 | .019 |
| Proportion with ≥7% increase in body weight | 4 | 37/646 | 14/561 | 1.86 (1.00, 3.46) | 0 | .048 |
| Extrapyramidal symptoms | 4 | 29/687 | 20/691 | 1.46 (0.84, 2.53) | 0 | .176 |
aTEAEs, treatment-emergent adverse events.